In this blog, we are talking about how to obtain a CE mark for your medical device in Europe.
But what is the system like in the United States?
It must be done through the Food and Drug Administration (FDA). This is the consumer protection agency of the Federal Government of the United States. The FDA regulates medical devices and radiation-emitting devices, of which the last two are regulated by the Center for Devices and Radiological Health.
The CDRH evaluates the safety and effectiveness of medical devices before they enter the market. Likewise, it ensures that they remain safe once they hit the market.
WHAT IS A MEDICAL DEVICE FOR THE FDA?
For the FDA, the medical device is an instrument, device, machine, implant or in vitro reagent that includes components, parts, or accessories, that diagnose cure, treat or prevent a disease or condition.
This is accomplished by acting on the structure or function of the body in a way that does not involve chemical intervention or the use of drugs or medications.
This definition excludes software dedicated to the storage and support of administrative data and the transmission of electronic patient records.
HOW ARE THEY CLASSIFIED?
The classification is based on the description of the device (physical characteristics and intended use). The FDA classifies devices as Class I, Class II, or Class III.
The class of a device increases with the level of risk and is assigned a three-letter code, called a Product Code. This allows the FDA to group devices with similar intended uses.
As the risk of devices increases, so does regulatory scrutiny to ensure their safety and effectiveness. Controls can be general, special (through the premarket notification procedure, called (FDA 510 k), and pre-market approval (PMA).
Some devices may be exempt from applying to the FDA or from requiring 510 (k) or PMA. For example, Class I devices only have to pass general checks and most are exempt from submitting pre-market applications, but some may be required to have a 510 (k).
HOW TO INTRODUCE YOUR NEW MEDICAL DEVICE TO THE US MARKET?
There are 5 steps.
- Describe your product in detail, both the design of the product and its purpose. The purpose can be described in terms of the intended use as well as the indications for use. You must describe the duration of use of your product, as well as the type of patient it is aimed at, such as use for a certain age range, or disease condition.
- Confirm that the product is a medical device. This goes back to the FDA's legal definition of a medical device.
- Classify the product to determine if it is Class I, II, or III, and will generally inform you if it will be necessary to submit a regulatory application for the device to enter the market.
- Generate the necessary information to guarantee its safety and effectiveness. This is valid scientific evidence to support your device. This can include preclinical, animal, and clinical trials.
- Prepare and submit a pre-market request so that your product can enter the market. There are 5 types of pre-market applications, each with its own set of processes, applicable requirements, review time, and body of evidence.
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